510(k) · Cleared
ClearedVitek 2 Gram Positive Inducible Clindamycin Resistance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Apr 30, 2008 as substantially equivalent to K053097 (bioMerieux, Inc., 2005) after a 93-day review. Its family tree reaches back 1 generation to 2005. 1 of the 5 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Apr 30, 2008
- Review
- 93 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053097 (2005). 3 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK053097 Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2005 · Recalled (Class I)
- This deviceK080201 Vitek 2 Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK111909 Vitek 2 Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK260282 VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK181766 VITEK 2 AST-Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2018
Class I recalls in this family
- K053097 Vitek 2 Gram Positive Cefoxitin Screendirect predicate · 2005
Most influential descendants
Showing 3 of 3 · See all- K111909Vitek 2 Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2011 · cites it directly2descendants
- K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026 · 2 generations on0descendants
- K181766VITEK 2 AST-Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053097 | Vitek 2 Gram Positive Cefoxitin Screen | bioMerieux, Inc. | 2005 | Class I |
| 0 (this device) | K080201 | Vitek 2 Gram Positive Inducible Clindamycin Resistance | bioMerieux, Inc. | 2008 | — |
| +1 | K111909 | Vitek 2 Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | 2011 | — |
| +2 | K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | 2026 | — |
| +2 | K181766 | VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance | bioMerieux, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053097 | Vitek 2 Gram Positive Cefoxitin ScreenSummary page 1…ame: VITEK 2 AST-GP Inducible Clindamycin Resistance C. Predicate Device: VITEK 2 Gram Positive Cefoxitin Screen (K053097). D. 510(k) Summary: VITEK® 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test designed for antimicr… | 2005 |
| † | K050002 | Vitek 2 Compact | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111909 | Vitek 2 Streptococcus Inducible Clindamycin Resistance | 2011 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K053097Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2005 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. It is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with…
Read the full statement (103 words)
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. It is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae,and S. pneumoniae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080201: Vitek 2 Gram Positive Inducible Clindamycin Resistance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080201
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026